Aseptic Operations Expert (all genders)

Aubonne , Vaud, Switzerland

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: TN Switzerland
Region: Aubonne , Vaud

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Aseptic Operations Expert (all genders), Aubonne

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Job Reference:

b92e4c30c0fd

Job Views:

3

Posted:

02.04.2025

Expiry Date:

17.05.2025

Job Description:

As an Aseptic Operations Expert, you are responsible for ensuring that the aseptic practices and activities in place in the Fill & Finish department are in compliance with relevant GMP. Your responsibilities include:

1. Definition and implementation of the APS (Aseptic Process Simulation or Media Fill) strategy on aseptic production lines, ensuring on-the-floor oversight and organization of each APS in compliance with GMP rules and procedures.
2. Elaboration and drafting of the operational documentation required for the successful completion of APS activities (Risk Assessments, Protocols, Reports, Annual Plans, etc.).
3. Collaboration in the organization, management, and execution of air flow visualization studies (AVS or smoke tests), including strategy definition and drafting of related operational documentation.
4. Observing the aseptic behavior of production operators to ensure the quality of aseptic operations carried out by those involved in the aseptic core.
5. Carrying out training courses on good practice and aseptic behavior for staff working in the aseptic core.
6. Management of deviations, CAPA, and Change Control within the scope of activity.
7. Representing your activity in the event of regulatory audits and inspections (EMS).
8. Participation in assessing compliance with current regulatory requirements (Annex 1 EU GMP, FDA Guidelines, etc.) and future updates, assessing any gaps, and guiding the implementation of identified best practices.

Who you are:

1. Education in biotechnology or equivalent.
2. Mastery of the pharmaceutical environment, particularly aseptic filling processes and aseptic practices (3-6 years experience).
3. Knowledge of Good Manufacturing Practices (BPF / GMP), with in-depth knowledge of Annex 1 EU GMP.
4. Editorial quality (Procedures, risk analyses, deviations, etc.).
5. Team spirit, leadership, autonomy, proactivity, and good communication are qualities necessary for success.
6. French mother tongue/fluent Good level of English (minimum B2).

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